A Randomized, Double-Blind, Controlled Trial of the 17D Yellow Fever Virus Vaccine Given in Combination with Immune Globulin or Placebo: Comparative Viremia and Immunogenicity
A Randomized, Double-Blind, Controlled Trial of the 17D Yellow Fever Virus Vaccine Given in Combination with Immune Globulin or Placebo: Comparative Viremia and Immunogenicity
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DOI：
10.4269/ajtmh.2012.12-0179
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发表时间：
2013-01-01
影响因子：
3.3
通讯作者：
Mulligan, Mark J.
中科院分区：
文献类型：
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作者：
Edupuganti, Srilatha;Eidex, Rachel B.;Mulligan, Mark J.
我们评估了黄热病 (YF) 病毒疫苗与含有 YF 病毒中和抗体的人免疫球蛋白 (Ig) 共同给药是否会在不影响免疫原性的情况下减少疫苗接种后病毒血症，从而可能减轻与 YF 疫苗相关的不良事件。我们将 80 名参与者随机分为接受 YF 疫苗和 Ig 或 YF 疫苗和生理盐水安慰剂。对参与者进行了 91 天的随访，以评估安全性以及病毒血症和免疫原性的评估。两组之间出现病毒血症、血清转化、分化簇 (CD)-8(+) 和 CD4(+) T 细胞反应以及细胞因子反应的接种疫苗参与者的比例没有差异。这些结果反驳了近年来黄热病疫苗副作用报告增加的一种推定解释（即 1996 年之后，旅行诊所实践发生了变化，当时用疫苗预防甲型肝炎取代了旅行前 Ig 的常规使用，从而可能消除了 Ig 中存在的抗黄热病病毒抗体的附带黄热病疫苗减弱作用）（ClinicalTrials.gov 标识符：NCT00254826）。
We evaluated whether coadministration of the yellow fever (YF) virus vaccine with human immunoglobulin (Ig) that contained YF virus-neutralizing antibodies would reduce post-vaccination viremia without compromising immunogenicity and thus, potentially mitigate YF vaccine-associated adverse events. We randomized 80 participants to receive either YF vaccine and Ig or YF vaccine and saline placebo. Participants were followed for 91 days for safety and assessments of viremia and immunogenicity. There were no differences found between the two groups in the proportion of vaccinated participants who developed viremia, seroconversion, cluster of differentiation (CD)-8(+) and CD4(+) T-cell responses, and cytokine responses. These results argue against one putative explanation for the increased reporting of YF vaccine side effects in recent years (i.e., a change in travel clinic practice after 1996 when hepatitis A prophylaxis with vaccine replaced routine use of pre-travel Ig, thus potentially removing an incidental YF vaccine-attenuating effect of anti-YF virus antibodies present in Ig) (ClinicalTrials.gov identifier: NCT00254826).